Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
FDA 510(k) clearance K211975 · decided 2021-11-10
Clearance details
- K-number
- K211975
- Device name
- Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- Applicant
- Caldera Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-25
- Decision date
- 2021-11-10
- Days to decision
- 138 days
- Clearance type
- Special
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westlake Village, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.